Cleared Traditional

GRANULYTE DIALYSATE CONCENTRATE

K922005 · Fresenius USA, Inc. · Gastroenterology & Urology
Mar 1994
Decision
700d
Days
Class 2
Risk

About This 510(k) Submission

K922005 is an FDA 510(k) clearance for the GRANULYTE DIALYSATE CONCENTRATE, a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on March 30, 1994, 700 days after receiving the submission on April 29, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K922005 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1992
Decision Date March 30, 1994
Days to Decision 700 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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